ARISTADA INITIO Rx
Generic Name and Formulations:
Aripiprazole lauroxil extended-release injectable suspension 675mg/2.4mL; for IM inj.
Indications for ARISTADA INITIO:
In combination with oral aripiprazole, for initiation (or reinitiation after a missed dose) of Aristada when used to treat schizophrenia.
Not interchangeable with Aristada. Treatment-naive: establish tolerability with oral aripiprazole first. Give 675mg as IM inj into the deltoid or gluteal muscle in conjunction with oral aripiprazole 30mg as a single dose. Administer first Aristada inj on same day as Aristada Initio or ≤10 days after; avoid inj into same muscle. Missed doses or treatment reinitiation: see full labeling. CYP2D6 poor metabolizers, concomitant strong CYP2D6 inhibitors, or strong CYP3A4 inhibitors/inducers: avoid. Refer to Aristada monograph for dosing.
Increased mortality in elderly patients with dementia-related psychosis.
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Reevaluate periodically. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.
Concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or strong CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine); reduce Aristada dose if concomitant use >14 days; avoid with Aristada Initio. Concomitant strong CYP3A4 inducers (eg, carbamazepine, rifampin); consider increasing Aristada dose if concomitant use >14 days; avoid with Aristada Initio. Potentiate antihypertensives (eg, carvedilol, lisinopril, prazosin), benzodiazepines (eg, lorazepam); monitor BP and adjust dose; avoid with Aristada Initio. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).
Akathisia, headache, anxiety, insomnia, inj site pain, restlessness, orthostatic hypotension, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others.
For women exposed to Aristada Initio during pregnancy, contact the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.
Kit—1 (prefilled syringe + safety needles)
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